Senior Quality Risk & Data Integrity Specialist

Partner Therapeutics, Inc.; Seattle (WA); On-site; USD 110,000 - 137,000; Full time

Benefits offered by this job

Hybrid/Remote work program

Annual bonus

401(k) matching

ORCA pass (Seattle)

Tuition assistance

Job summary

Partner Therapeutics, Inc. seeks a Quality Risk & Compliance Specialist (Risk Management) to identify, assess, document, and monitor quality risks across cGMP manufacturing, testing, and support operations in the Seattle area.

The ideal candidate will lead formal risk assessments (FMEA, risk ranking), ensure data integrity, support regulatory readiness, and collaborate with cross-functional partners to implement effective mitigations and compliant processes.

Qualifications

• Strong knowledge of QRM in a regulated GxP environment.
• Hands-on in facilitating formal risk assessments with cross-functional teams.
• Experience applying risk tools like FMEA and risk ranking.
• Ability to translate complex information into risk reports and mitigations.

Responsibilities

• Serve as SME for Quality Risk Management and Data Integrity programs.
• Lead risk assessments using FMEA, design FMEA, and other QRM methods.
• Support risk-based change controls and maintain living risk library.
• Coach SMEs on mitigation strategies and risk-based decision making.
• Ensure documentation in MasterControl and verify residual risk reductions.

Skills

Quality Risk Management

Data Integrity

GxP environments

Risk assessment facilitation

FMEA

Regulatory inspections support

Clear risk reporting

MS Office (Word/Excel)

Education

Bachelor's degree in Science/CS/Quality Engineering

High school diploma or GED

Tools

MasterControl

SharePoint

Smartsheet

Advanced Risk Assessment software

Job description

Partner Therapeutics, Inc. seeks a Quality Risk & Compliance Specialist (Risk Management) to identify, assess, document, and monitor quality risks across cGMP manufacturing, testing, and support operations in the Seattle area.

The ideal candidate will lead formal risk assessments (FMEA, risk ranking), ensure data integrity, support regulatory readiness, and collaborate with cross-functional partners to implement effective mitigations and compliant processes.